AxSOS 3 AF System And AxSOS 3 Ti System

Plate, Fixation, Bone

Stryker GmbH

The following data is part of a premarket notification filed by Stryker Gmbh with the FDA for Axsos 3 Af System And Axsos 3 Ti System.

Pre-market Notification Details

Device IDK200398
510k NumberK200398
Device Name:AxSOS 3 AF System And AxSOS 3 Ti System
ClassificationPlate, Fixation, Bone
Applicant Stryker GmbH 325 Corporate Drive Mahwah,  NJ  07430
ContactPaul Nelson
CorrespondentPaul Nelson
Stryker GmbH 325 Corporate Drive Mahwah,  NJ  07430
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-18
Decision Date2020-06-05

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